Cannula insertion system

ABSTRACT

A cannula insertion system for inserting a cannula into a human or animal body, includes a cannula and a cannula insertion device to hold and insert the cannula into the human or animal body in an insertion direction. The cannula insertion system includes a safety device configured to retract the cannula or to release the cannula from the cannula insertion device when a force exerted on the cannula in a direction perpendicular to the insertion direction results in exceeding a respective safety threshold value.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.17/421,045, filed Jul. 7, 2021, which is the National Stage ofInternational Application No. PCT/NL2020/050009, filed Jan. 7, 2020,which claims the benefit of Netherlands Application No. 2022350, filedJan. 7, 2019, the contents all of which are incorporated by referenceherein.

FIELD OF THE INVENTION

The present invention relates to a cannula insertion system forinserting a cannula into a human or animal body.

BACKGROUND OF THE INVENTION

US2008/0275396 A1 discloses an automated cannula insertion system forautonomously inserting a cannula into a blood vessel of a human or ananimal, the contents of which are herein incorporated by reference inits entirety.

The cannula insertion system of US2008/0275396 A1 comprises anacquisition module that allows for determining at least a location of ablood vessel underneath the skin and is enabled to determine a puncturelocation that is suitable for inserting a cannula into the blood vessel.The cannula insertion system comprises an actuator for moving andaligning the cannula to a determined position and to autonomously insertthe cannula into the blood vessel for multiple purposes, such as bloodwithdrawal, venous medication and infusions.

It is necessary that an automated cannula insertion system forautonomously inserting a cannula into a human or animal body, forexample into a blood vessel of a human or an animal, is safely operated.When a needle is inserted into a blood vessel, unnecessary damage to theblood vessel and the tissues surrounding the blood vessel should beavoided. Moreover, since the insertion of the cannula into the bloodvessel may be performed completely automatically, an operator of thecannula insertion system may not or not timely react to anymalfunctioning of the cannula insertion system which may introduce apractical risk to the use of an automated cannula insertion system.

WO 00/56213 A1 discloses a locating and insertion device configured tolocate a vein and introduce a needle into the vein. During insertion ofthe needle into a body the pressure exerted in axial direction on thevein is monitored by a pressure sensor. Penetration of the vessel wallis determined by a force-dip in the force-displacement profile of theneedle penetration. When this force-dip is detected by the locating andinsertion device, further insertion of the needle is stopped since theneedle has penetrated the vessel wall. No safety device has beendescribed in WO 00/56213.

US 2015/0065916 A1 discloses a fully automated vascular imaging andaccess system to insert a needle into a vein of a patient. In thissystem also, a pressure sensor is used to measure the axial pressure onthe needle and to stop the needle insertion when a change in the appliedforce indicates a penetration of the vessel wall.

WO2017/145141 A1 discloses a system and device for detecting bloodvessels. The system comprises a force sensor for measuring an axialforce on the needle. Insertion of the needle is stopped when a raise inthe force measured by the force sensor is determined in order to avoidpenetration of the blood vessel.

SUMMARY OF THE INVENTION

An object of the present invention is to provide a cannula insertionsystem that improves the safety during the introduction of a cannulainto a human or animal body, for example a blood vessel of a human oranimal, whereby preferably the risk of damage to the tissue in which thecannula is placed, for example due to sudden movements of the cannulawith respect to the blood vessel, is substantially reduced. For example,movements in a direction at least partially perpendicular to theinsertion direction of the needle may cause substantial damage to thetissue in which the cannula is placed.

The present invention provides a cannula insertion system as describedherein.

In accordance with the present invention, the cannula insertion systemcomprises a safety device configured to retract the cannula or torelease the cannula from the cannula insertion device in case a safetyrequirement is not met. This safety requirement is not met when a forceexerted on the cannula, for example on a distal end of the cannula, in adirection perpendicular to the insertion direction results in exceedinga safety threshold value.

The safety threshold value may for example be a maximum torque resultingfrom the force that may be exerted on the cannula and/or a maximumtransverse force that may be exerted on the cannula.

In an embodiment, another safety requirement may not be met when a forceexerted on the cannula, for example on a distal end of the cannula, in adirection parallel to the insertion direction results in exceeding arespective safety threshold value.

The cannula of the cannula insertion system will be inserted into a bodypart, for example an arm or leg, of a human or animal. Sudden movementsof this body part with respect to the cannula insertion system orunexpected movements of the cannula insertion system with respect tothis body part, may result in potential damage of the tissue in whichthe cannula is inserted, for example damage of a blood vessel orsurrounding tissues thereof. These potential dangerous movements willresult in a transverse force and/or parallel force being exerted on thedistal end of the cannula, i.e. the part of the cannula that may beinserted into the human or animal body in a direction perpendicularand/or parallel to the insertion direction of the cannula into the humanor animal body.

In an embodiment of the invention, the safety device is arranged toreact to such transverse force, i.e. the force being exerted on thedistal end of the cannula in a direction perpendicular to the insertiondirection of the cannula and/or such parallel force, i.e. the forcebeing exerted on the distal end of the cannula in a direction parallelto the insertion direction of the cannula. In particular, the safetydevice is arranged to carry out a safety measure when the transverseforce and/or parallel force results in exceeding a respective safetythreshold value. The safety threshold value is preferably selected suchthat transverse and/or parallel forces that may be exerted on the distalend of the cannula during an insertion of the cannula into a human oranimal body are below the safety threshold value. Transverse and/orparallel forces, for example caused by sudden movements of the patientand/or unintended erroneous movements due to positioning of the cannulainsertion device, that may cause substantial damage to the tissue inwhich the cannula is inserted, which normally should not occur during asuccessful insertion of the cannula into the human or animal body shouldbe above the respective safety threshold value.

In an embodiment, there is a first safety threshold value for a forceexerted on the distal end of the cannula in a direction perpendicular tothe insertion direction and a second safety threshold value for a forceexerted on the distal end of the cannula in a direction parallel to theinsertion direction. The first safety threshold value and the secondsafety threshold value may have the same or different threshold values.

The first safety threshold value may for example be provided as a forceor torque that not may exceeded. The first safety threshold value mayalso be defined as a maximum angular misalignment of the cannula withrespect to the insertion direction of the cannula. The second safetythreshold value may for example be a maximum force being exerted on thedistal end of the cannula in the insertion direction.

According to a first safety measure, the cannula may be automaticallyreleased from the cannula insertion device when the transverse and/orparallel force results in exceeding a respective threshold value. Afterthe cannula being released from the cannula insertion device, thecannula may freely move together with the body part in which the cannulais introduced. Therewith damage to tissue of the human or animal bodydue to relative movement between the cannula insertion device and thebody part is substantially reduced.

According to a second safety measure, the cannula may be automaticallyretracted in a retraction direction opposite to the insertion directionwhen the transverse force and/or parallel force on the cannula, forexample the distal end of the cannula, results in exceeding therespective safety threshold value. By retraction of the cannula, thecannula is pulled out of the human or animal body, for example to avoidthe risk of damaging tissue due to a transverse movement of the distalpart of the cannula with respect to the body part in which the cannulawas inserted.

It is remarked that, in this application, forces having a vectorcomponent in the direction perpendicular to the insertion direction ofthe cannula are regarded to comprise a force perpendicular to theinsertion direction of the cannula. Correspondingly, forces having avector component in the direction parallel to the insertion direction ofthe cannula are regarded to comprise a force parallel to the insertiondirection of the cannula.

In an embodiment, the safety device comprises a cannula holder arrangedto hold the cannula if the force exerted on the cannula, for example thedistal end of the cannula in the direction perpendicular and/or parallelto the insertion direction is below the respective safety thresholdvalue, and to release the cannula if the force exerted on the cannula,for example the distal end of the cannula in the direction perpendicularand/or parallel to the insertion direction results in exceeding therespective safety threshold value.

In such embodiment, according to the first safety measure, the cannulais held, during insertion of a cannula, by a cannula holder that isconfigured to release the cannula if the transverse force and/orparallel force results in exceeding the respective safety thresholdvalue.

In an embodiment of the cannula holder, the cannula holder comprises:

-   -   a coupling element arranged on one of the cannula and cannula        insertion device;    -   a base and a detent mechanism arranged on the other of the        cannula and cannula insertion device;    -   wherein the coupling element comprises a base surface to        cooperate with the base and a detent surface, opposite to the        base surface, to cooperate with the detent mechanism,    -   wherein the coupling element is configured to be releasably held        between the base and the detent mechanism, whereby the detent        surface engages the detent mechanism and the base surface        engages the base,    -   wherein movement of the detent surface in a direction        perpendicular to a line on which the detent mechanism and the        base are provided will result in release of the coupling element        from the detent mechanism and the base.

In such embodiment, the coupling element may be arranged, manually orautomatically, between the base and the detent mechanism, whereby thebase surface engages the base and the detent surface engages the detentmechanism. The detent mechanism and the base are preferably arranged ona line parallel to the insertion direction of the cannula.

When a transverse force is exerted on the distal end of the cannula, theengagement between the base and base surface may act as a rotation pointaround which the coupling element may rotate with respect to the base,in particular when the transverse force on the distal end of the cannularesults in exceeding the safety threshold value. As a result of suchrotation, the detent surface may displace with respect to the detentmechanism such that the engagement between the detent surface and thedetent mechanism is released. As a result, the coupling element is nolonger held between the base and the detent mechanism.

In an embodiment, the detent mechanism comprises a detent and a spring,wherein the spring is arranged to bias the detent towards the base. Thebiasing force of the spring creates a clamping of the coupling elementbetween the detent and the base. The biasing force is therefore ameasure for the safety threshold value of the cannula holder.

In an embodiment, the detent is a sphere and wherein the detent surfaceis a concave surface mating with a spherical surface of the sphere.

In an embodiment, the base comprises a projection extending towards thedetent mechanism, wherein the base surface comprises a notch mating withthe projection.

In an embodiment, the coupling element is mounted on the cannula andwherein the cannula holder comprises a housing comprising a recessmounted on the cannula insertion device, wherein the recess is arrangedto receive the coupling element, wherein the housing supports the detentmechanism at one side of the recess and the base at an opposite side ofthe recess.

In an embodiment, the cannula is a disposable unit, and the couplingelement is an integral part of the cannula.

In an embodiment, the cannula insertion system comprises a cannulaholder sensor arranged to determine a position of a cannula held by thecannula holder. The position of the cannula may be determine in one ormore degrees of freedom, including one or more translation positionsand/or one or more rotation positions.

The cannula holder sensor may be arranged at any suitable location, suchas a cannula insertion device positioning system, a sensor or apositioning system for such sensor. The cannula holder sensor may forexample be arranged on a contact sensor, such as an ultrasoundtransducer or a positioning system for such contact sensor to determinea relative position of the cannula with respect to the contact sensor.This allows to determine a position of the cannula with respect to alocation where a sensor signal is obtained.

The cannula holder sensor may also be arranged at a separate locationwhere it can determine a relative position of the cannula with respectto the contact sensor, by measuring from this separate location both theposition of the cannula and the position of the contact sensor.

In an embodiment, the cannula holder sensor is arranged to determinealignment of the cannula with the insertion direction of the cannulainsertion device. During insertion of a cannula into a body part, thecannula will be moved by the cannula insertion device in the insertiondirection. To ensure that the cannula will be properly moved into thebody part the cannula holder sensor may determine whether the cannula isproperly aligned with the insertion direction of the cannula insertiondevice.

In an embodiment, the cannula holder sensor can also be used todetermine whether a cannula is held by the cannula holder, for examplebefore the automatic insertion procedure of the cannula into the bodypart is started.

In an embodiment, the safety device comprises, according to the secondsafety measure, a cannula retraction device arranged to retract thecannula in a retraction direction opposite to the insertion direction,when the force exerted on the cannula, for example the distal end of thecannula in the direction perpendicular and/or parallel to the insertiondirection results in exceeding the safety respective threshold value. Acannula retraction device may be used to automatically retract thecannula in the retraction direction. This retraction direction isparallel but opposite to the insertion direction to ensure that thecannula is pulled out of the body part of the human or animal withminimal damage to the tissue of the body part in which the cannula isplaced.

The cannula retraction device is preferably a mechanical device, i.e.the cannula retraction device may retract the cannula automaticallywithout an electromotor or hydraulic or pneumatic actuator, when thetransverse force and/or parallel force on the distal part of the cannularesults in exceeding the safety threshold value.

In an embodiment, the cannula retraction device comprises:

-   -   a linear guide extending in the retraction direction and mounted        on the cannula insertion device, in which the cannula is        slidably movable between an insertion position and a retracted        position,    -   a spring element arranged to bias the cannula to the retracted        position,    -   a blocking device arranged to block movement of the cannula from        the insertion position to the retracted position, when a force        exerted on the cannula, for example the distal end of the        cannula in the direction perpendicular and/or parallel to the        insertion direction is below the respective safety threshold        value and to allow movement of the cannula from the insertion        position to the retracted position when the force exerted on the        cannula, for example the distal end of the cannula in the        direction perpendicular and/or parallel to the insertion        direction results in exceeding the respective safety threshold        value.

The blocking device may for example be a clamping device that clamps thecannula in the insertion position.

In an embodiment, the cannula insertion system further comprises:

a positioning system supporting the cannula insertion device, and

a control device arranged to control the positioning system to position,on the basis of a determined location for insertion of the cannula intothe human or animal body, the cannula insertion device in a suitableposition to insert the cannula into the human or animal body.

The positioning system and the control device may be used toautomatically insert the cannula into the desired body part of the humanor animal.

In an embodiment, the safety device comprises a sensor arranged tomeasure a signal representative for the force exerted on the needle in adirection perpendicular and/or parallel to the insertion direction,wherein the cannula holder is controlled by the control device, andwherein the control device is arranged to control the cannula holder torelease the cannula when the force exerted on the cannula, for examplethe distal end of the cannula in a direction perpendicular and/orparallel to the insertion direction results in exceeding the respectivesafety threshold value.

In this embodiment a sensor may be provided to measure a signalrepresentative for the transverse force and/or parallel force exerted onthe cannula, for example the distal end of the cannula. This sensor maybe a force sensor or a torque sensor, but also a sensor arranged todetermine a position or rotational position of the cannula. Thisposition or rotational position may for example be determined by camerasusing visible or infrared light, a distance sensor, a rotationalencoder, or such. The sensor signal of this sensor may be fed into thecontrol device.

It is remarked that the cannula holder may also be controlled by acontrol device other than the control device of the positioning system.

The control device may compare the sensor signal with a safety thresholdvalue. Further, the control device is arranged to control a cannulaholder that releasably holds the cannula. The cannula holder may forexample comprise a mechanical gripper or magnetic holding device thatcan be arranged in a holding state in which the cannula can be held bythe cannula holder and a release state in which the cannula is not heldby the cannula holder. When the safety threshold value is exceeded, thecontrol device may control the cannula holder to switch from the holdingstate to the release state such that the cannula is released from thecannula holder.

In an embodiment, the safety device comprises a sensor arranged tomeasure a signal representative for the force exerted on the needle in adirection perpendicular and/or parallel to the insertion direction, andwherein the control device is arranged to control the positioning systemand/or the cannula insertion device to retract the cannula in theretraction direction when the force exerted on the cannula, for examplethe distal end of the cannula in a direction perpendicular and/orparallel to the insertion direction results in exceeding the respectivesafety threshold value.

In this embodiment, a similar sensor may be used, but the control deviceis now arranged to control the positioning system and/or the cannulainsertion device to retract the cannula in the retraction direction whenthe transverse force and/or the parallel force exerted on the cannula,for example the distal end of the cannula results in exceeding thethreshold value.

In the embodiments in which the release of the cannula or the retractionof the cannula is controlled by a control device, the control device mayalso be arranged to control the cannula holder or the positioning systemand/or the cannula insertion device to release or retract the cannula,respectively, when another safety criterion is not fulfilled. Suchsafety criterion may for example not be fulfilled when an error isdetected in the cannula insertion system. Such error may for instancerelate to a temperature level in the cannula insertion system exceedinga maximum allowable temperature level, a signal indicating that a needleis not properly coupled to the needle insertion device or that a cannulais not properly aligned with the insertion direction the cannulainsertion device. The control device may also be arranged to control thecannula holder or the positioning system and/or the cannula insertiondevice to release or retract the cannula, respectively, when there is afailure in the power provision of the cannula insertion system. In anembodiment, the safety device comprises an adjustment mechanism toadjust the safety threshold value. It may be advantageous that thesafety threshold value may be adjusted. For example, in a mechanicalcannula holder that releasably holds the cannula on the basis of aclamping force, the level of this clamping force may be adjusted toadjust the level of the safety threshold value.

In an embodiment, the safety device is configured to retract the cannulaor to release the cannula from the cannula insertion device when a poweroutage occurs. It is undesirable that the cannula will remain in a humanor animal body in case of a power outage. Therefore, the cannulainsertion system may also be configured to release or retract thecannula when a power outage occurs.

In an embodiment, the safety device comprises a cannula retractiondevice arranged to retract the cannula in a retraction directionopposite to the insertion direction, when the power outage occurs.

In an embodiment, the cannula insertion device comprises an insertionactuator to move the cannula at least from the retracted position to theinsert position, and wherein the cannula retraction device comprises abiasing element arranged to bias the cannula to the retracted position,such that for example in case of a power outage the biasing elementpushes the cannula to the retracted position. The cannula insertiondevice is used to insert the cannula into the human or animal body bymoving, after the cannula insertion device has been positioned in asuitable position, the cannula from the retracted position to theinsertion position. When the insertion actuator fails the biasingelement, for instance a spring, may push the cannula back to theretracted position. In the retracted position, the cannula will nolonger be arranged in the human or animal body.

In an embodiment, the cannula insertion device may comprise a linearinsertion guide along which the cannula is movable between the insertionposition and the retracted position.

In an alternative embodiment, the cannula retraction device comprises:

-   -   a linear guide extending in the retraction direction and mounted        on the cannula insertion device, in which the cannula is        slidably movable between an insertion position and a retracted        position,    -   a biasing element arranged to bias the cannula to the retracted        position,    -   an electrically operated blocking device arranged to block        movement of the cannula from the insertion position to the        retracted position, when energized, and to allow movement of the        cannula from the insertion position to the retracted position,        when not energized.

In an embodiment, the cannula insertion system is constructed toautonomously insert the cannula into a blood vessel. This means that thecannula insertion system may be configured to carry out, without anyinteraction of a human operator, the following steps:

-   -   measuring, with a blood vessel location sensor, one or more        sensor signals representative for a location of the blood        vessel,    -   determining, with a processing device, a location of a blood        vessel on the basis of the one or more sensor signals,    -   positioning, on the basis of the determined location of the        blood vessel, with the positioning system, the cannula insertion        device in a suitable position to insert the cannula into the        blood vessel, and    -   inserting the cannula into the blood vessel.    -   In an embodiment, the cannula insertion system may further be        configured to carry out the step of measuring, with a sensor, a        signal representative for the force exerted on the cannula in a        direction perpendicular and/or parallel to the insertion        direction, and    -   controlling with the control device an active cannula holder to        release the cannula when the force exerted on the cannula, for        example the distal end of the cannula in a direction        perpendicular and/or parallel to the insertion direction results        in exceeding the respective safety threshold value.

In another embodiment, the cannula insertion system may further beconfigured to carry out the step of measuring, with a sensor, a signalrepresentative for the force exerted on the needle in a directionperpendicular and/or parallel to the insertion direction, and

-   -   controlling with the control device the positioning system        and/or the cannula insertion device to retract the cannula in        the retraction direction when the force exerted on the cannula,        for example the distal end of the cannula in a direction        perpendicular and/or parallel to the insertion direction results        in exceeding the respective safety threshold value.

In an embodiment, the cannula is a needle. The cannula may be any tubelike element that is configured to be introduced into a human or animalbody, for example into a blood vessel. Preferably, the cannula is aneedle, in particular a needle suitable to draw blood from a bloodvessel.

In an embodiment, the cannula insertion system is constructed toautonomously draw blood from a blood vessel. In other embodiments, thecannula insertion system may be used to insert a cannula into a bodypart of a human or animal, for example for venous medication, infusions,biopsy, robot surgery, laparoscopic surgery, etc.

According to a further aspect of the invention, there is provided acannula insertion system for inserting a cannula into a human or animalbody, comprising:

-   -   a cannula; and    -   a cannula insertion device to hold and insert the cannula into        the human or animal body in an insertion direction, wherein the        cannula insertion device comprises a cannula holder to        releasably hold the cannula,    -   characterized in that the cannula insertion system comprises a        cannula holder sensor arranged to determine whether a cannula is        held by the cannula holder and/or to determine a position of the        cannula, for example with respect to the insertion direction of        the cannula insertion device.

It is desirable that the cannula is properly aligned with the insertiondirection of the cannula insertion device, i.e. a longitudinal axis ofthe cannula is parallel to the insertion direction. The cannulainsertion system may comprise a cannula holder sensor for examplearranged to determine whether a cannula is held by the cannula holderand/or whether a cannula held by the cannula holder is properly alignedwith the insertion direction ID of the cannula insertion device.

The cannula holder sensor may be connected to a control device of thecannula insertion system, that may check that the cannula is properlyheld by the cannula insertion device before the procedure of automaticinsertion of the cannula into a body part is started. The cannula holdersensor may be used to compensate for relatively large tolerances in thecannula or the cannula insertion device.

In an embodiment, the cannula holder sensor is configured to determine aposition of the cannula, for example the distal end of the cannula in atleast one degree of freedom, for example, three or six degrees offreedom. The position of the cannula, for example the distal end of thecannula may be determined with respect to the cannula insertion deviceand/or with respect to the human or animal body and/or with respect toone or more sensors to determine a one or more features orcharacteristics of the human or animal body, for example with respect toa contact sensor, such as a ultrasound transducer.

In an embodiment, the relative positions of the cannula, for example thedistal end of the cannula, the cannula insertion device, the human oranimal body and/or the location of other sensors may be determined onthe basis of sensor signals obtained by multiple sensors, one of thesesensors being the cannula holder sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the cannula insertion systemof the invention will now be explained by description of an embodimentof the invention, whereby reference is made to the appended drawings, inwhich:

FIG. 1 shows schematically a cannula insertion system according to anembodiment of the invention;

FIG. 2 shows an embodiment of a cannula insertion device and cannula inmore detail;

FIG. 3 shows an embodiment of a cannula holder arranged to releasablyhold a cannula;

FIGS. 4a, 4b and 4c show different states of the cannula holder of FIG.3;

FIGS. 5a and 5b show different states of a cannula retraction devicethat can be applied as a safety device in the cannula insertion systemof FIG. 1;

FIG. 6 shows a further alternative embodiment of a cannula insertionsystem according to the invention, and;

FIG. 7 shows another further alternative embodiment of a cannulainsertion system according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a cannula insertion system, generally denoted by referencenumeral 1. The cannula insertion system 1 is configured to autonomouslyinsert a cannula 2, for example a needle into a blood vessel V of ahuman or animal. The cannula insertion system 1 as shown in FIG. 1 is inparticular configured to autonomously draw blood from a blood vessel. Inalternative embodiments, the cannula insertion system 1 may beconfigured to arrange a cannula in a blood vessel V for venousmedication and/or infusions. An automatic cannula insertion system mayalso be configured as a biopsy device, a surgery robot, a laparoscopicrobot, or any other system that may use an autonomous cannula insertionsystem in a body part of human or animal.

To draw blood from the blood vessel V, the cannula insertion system 1may be arranged to determine a location of a blood vessel underneath theskin S of the human or animal, insert a cannula 2 into the blood vesselV and draw blood from the blood vessel V without direct interaction ofan operator of the cannula insertion system 1.

Autonomous cannula insertion systems are known in the prior art. Forexample, US2008/0275396 A1 discloses an automated cannula insertionsystem for autonomously inserting a cannula into a blood vessel of ahuman or an animal, the contents of which are herein incorporated byreference in its entirety.

The cannula insertion system 1, shown on FIG. 1, comprises an ultrasoundtransducer 3 to obtain one or more sensor signals that arerepresentative for the location of a blood vessel V in the human oranimal. The ultrasound transducer 3 is a contact sensor. During usecontact between the ultrasound transducer 3 and the skin S is requiredin order to obtain relevant data with respect to the location of theblood vessel V. An ultrasound transducer positioning system 4 isprovided to guide the ultrasound transducer along the skin S of thehuman or animal in a target area T. This target area T is an area of theskin S underneath which the presence of a blood vessel V suitable forinsertion of a cannula 2 is expected and which is examined by theultrasound transducer 3. A control device 5 controls the position of theultrasound transducer 3 by sending a control signal to the ultrasoundtransducer positioning system 4.

The target area T may be determined by obtaining images of the skin of ahuman or animal, for example using a NIR (near infrared) sensor 30, anddetermining on the basis of the images an area in which it is likelythat a blood vessel suitable for insertion of a cannula will be found.

The ultrasound transducer 3 provides a sensor signal representative fora location of the blood vessel V. The sensor signal is fed into aprocessing device 6 which is arranged to process the sensor signal. Thecontrol device 5 and the processing device 6 may be comprised in asingle processer 7, such as a PC.

In practice, multiple sensors may be used to collect data relevant forthe determination of the location of a blood vessel V underneath theskin S of a human or animal. These sensors may include contact sensors,that need to be placed on the skin S to obtain relevant data, andnon-contact sensors, that can obtain information at a distance from theskin S.

On the basis of the sensor signal, or sensor signals, the processingdevice 6 determines the location of a blood vessel V suitable for theinsertion of the cannula 2. On the basis of this location, theprocessing device 6 may determine an insertion path for insertion of thecannula 2 into the blood vessel V.

The cannula 2 is arranged on a cannula insertion device 8. The cannulainsertion device 8 is arranged to insert the cannula 2 in an insertiondirection ID through the skin S and into the blood vessel V along theinsertion path determined by the processing device 6. A longitudinalaxis of the cannula 2 is aligned with the insertion direction ID.

The cannula insertion device 8 is supported by a positioning system 9,for example a robot arm, that is arranged to bring the cannula insertiondevice 8 in a position from which the cannula insertion device 8 maymove the cannula 2 along the insertion path. The cannula insertiondevice 8 and the positioning system 9 are controlled by the controldevice 5.

FIG. 2 shows an embodiment of a needle insertion device 8 supporting acannula 2 in more detail. The needle insertion device 8 comprises alinear insertion actuator 8 a arranged to move the cannula 2, whenoperated by the processing device 6, in the insertion direction ID froma retracted position to an insertion position to insert the cannula 2into a body part, in particular a blood vessel V, of a human or animal.The cannula insertion device may comprise a linear insertion guide 8 calong which the cannula 2 is movable between the insertion position andthe retracted position.

A biasing element 8 d, for example a spring may be arranged to bias thecannula 2 to the retracted position. When the linear insertion actuator8 a fails, for example due to a power outage, the biasing element 8 dwill push the cannula 2 back to the retracted position. In the retractedposition, the cannula 2 will no longer be arranged in the human oranimal body. Thus in case of a power outage, the cannula 2 willautomatically be pulled out of the human or animal body.

The positioning system 9 comprises at least one actuator 9 a configuredto rotate the cannula insertion device 8 with respect to the positioningsystem 9 in order to adapt the insertion direction ID of the needleinsertion device 8 as defined by the actuating movement of the linearinsertion actuator 8a.

It is remarked that in alternative embodiments, the cannula insertiondevice 8 and the position system 9 may be integrated in a single cannulapositioning device.

The cannula as shown in FIG. 2 comprises a needle tube 2 a having adistal end to be introduced into the desired body part of the human oranimal, and a connection device 2 b arranged at the proximal end of theneedle tube 2 a. The connection device 2 b is configured to mount thecannula 2 to the cannula insertion device. The connection device 2 bfurther comprises a connection port 2 c to connect the needle tube 2 ato a further device, such as a tube, for example a blood collection tubeor infusion tube, or a blood collection container.

Once the cannula 2 is inserted into the blood vessel V, the cannulainsertion system 1 is arranged to draw blood from the human or animal byfilling one or more blood collection containers with blood. The cannulainsertion system may comprise a blood container handling system to filland close these blood collection containers. When sufficient blood hasbeen drawn from the human or animal, the cannula insertion device 8 maywithdraw the cannula 2 from the blood vessel V and out of the skin S.Thereafter, the positioning system 9 may move the cannula insertiondevice 8 to a location where there is no or substantially less risk thatthe cannula 2 will penetrate the skin S, when, for example, the bodypart in which the blood vessel V is present, such as an arm is withdrawnfrom a cannula insertion position in the cannula insertion system 1.

When the cannula 2 is present in the blood vessel V, or any other bodypart, it is undesirable that a substantial transverse force, i.e. aforce exerted on the distal end of the cannula in a directionperpendicular to the insertion direction ID of the cannula 2 is exerted,since such transverse force may lead to substantial damage of the bloodvessel V or damage of the tissue surrounding the blood vessel V, forexample the skin S. The transverse force may for example result fromsudden movements of the body part in which the cannula is inserted withrespect to the cannula insertion system 1, or an erroneous unintendedmovement caused by the positioning system 9.

To prevent that an excessive transverse force is exerted on the bloodvessel or surrounding tissues, a safety device is provided. The safetydevice is in the shown embodiment provided as a cannula holder 10 whichis configured to releasably hold the cannula 2. Before the insertionprocedure is started, the cannula 2 may manually or automatically beplaced in the cannula holder 2.

It is desirable that the cannula 2 is properly aligned with theinsertion direction ID, i.e. a longitudinal axis of the cannula 2 isparallel to the insertion direction. Therefore, as shown in FIG. 2, thecannula insertion system comprises a cannula holder sensor 25 arrangedto determine a position of the cannula 2 held by the cannula holder 10.The measured position of the cannula 2 can for example be used to checkwhether the cannula 2 is properly aligned with the insertion directionID of the cannula insertion device 8. The cannula holder sensor 25 canbe connected to the control device 5 allowing the control device 5 tocheck that the cannula 2 is properly held by the cannula holder 10before the procedure of automatic insertion of the cannula 2 into a bodypart is started.

In case the measurements of the cannula holder sensor 25 indicate thatthe cannula is not properly aligned with the insertion direction ID, thecannula holder 10 may be arranged to adapt the position, for example theorientation, of the cannula 2 to align the cannula with the insertiondirection ID. In this way tolerances in cannula 2 and/or in the cannulainsertion device may be compensated.

The cannula holder sensor 25 may, in addition or as an alternative, beused to check the presence of the cannula 2 in the cannula holder 10.This may for example be applied when the cannula 2 is automaticallyaligned with the insertion direction ID upon placement of the cannula 2into the cannula holder 10.

The cannula holder sensor 25 may be configured to determine a positionof the cannula 2 in at least three degrees of freedom, for example sixdegrees of freedom. The cannula holder sensor 25 may be configured todetermine relative position changes between the distal end of thecannula 2 and the target area T of the human or animal body. Anyunexpected movement between the distal end of the cannula 2 and thetarget area T may indicate a movement of the target area T, e.g. an armmovement.

Such sensor signal of the cannula holder sensor 25 may also be used toactivate a safety device to release the cannula from the cannula holder10 and/or to retract the cannula 2.

FIG. 3 shows an embodiment of the cannula holder 10 in more detail. Thecannula holder 10 comprises a housing 11 having a recess 12. The recess12 is configured to receive a coupling element 13 mounted on the cannula2. The coupling element 13 may be an integral part of the cannula 2, forexample an integral part of the connection device 2 b of the cannula 2shown in FIG. 2. In another embodiment, the coupling element 13 may be aseparate element, for example having a holder to hold the cannula 2.

In the recess 12 a base 14 and a detent mechanism 15 are arranged atopposite sides of the recess 12. The base 14 and the detent mechanism 15are aligned with respect to a line L which is parallel to the insertiondirection ID of the cannula 2, whereby the location of the base 14 ismore proximal in the insertion direction ID compared to location of thedetent mechanism 15.

The detent mechanism 15 comprises a spherical detent 16, a spring 17 anda detent base 18. The detent base 18 comprises an outer screw threadwith which it screwed into a screw channel in the housing 11. The spring17 biases with a biasing force the detent 16 towards the base 14. Thebiasing force of the spring may be adapted by rotation of the detentbase in the screw channel wherein it is placed. Therewith, the safetythreshold value may be adjusted.

The coupling element 13 comprises a base surface 19 to cooperate withthe base 14 and a detent surface 20, opposite to the base surface 16, tocooperate with the detent mechanism 15. As shown in FIG. 3, the couplingelement 13 may be held between the base 14 and the detent mechanism 15,whereby the detent surface 20 engages the detent mechanism 15, inparticular the detent 16, and the base surface 19 engages the base 14.The spring 17 biases the detent 16 against the detent surface 20. Thedetent surface 20 is provided with a concave surface that mates with thespherical surface of the detent 16.

The base 14 comprises a pointed projection 21 extending towards thedetent mechanism 15. The base surface 19 may comprises a notch matingwith the projection 21.

When a transverse force is exerted on a distal end of the cannula 2, thecoupling element 13 will have a tendency to make a rotation R withrespect to the housing 11. The engagement of the projection 21 and thenotch in the base surface 19 may form a rotation point for such rotationof the coupling element 13.

The biasing force of the spring 17 that pushes the detent 16 into theconcave detent surface 20, prevents rotation R of the coupling element13 as long the force exerted on the distal end of the cannula 2 isinsufficient to overcome the biasing force with which the detent 16 ispushed into the concave detent surface 20 of the coupling element 20.When the force exerted on the distal end of the cannula 2 is sufficientto move the detent 16 in the direction of the detent base 18, therebycompressing the spring 17, the safety threshold value is exceeded.

In that case the coupling element 13 may be rotated in rotationdirection R with respect to the location of engagement between the base14 and the base surface 19. When rotation R continues the couplingelement 13 is no longer held between the base 14 and the detentmechanism 15. As a result, the cannula 2 is released from the cannulainsertion device 8. The cannula may still be in the body part in whichit is inserted, but relative movement between the body part and theneedle insertion device 8 can take place without the cannula beingpulled with a large force in a transverse direction in the body part inwhich it is inserted.

FIGS. 4a, 4b and 4c show the different stages of release of the couplingelement 13 from the cannula holder 10.

FIG. 4a shows the coupling element 13 held, by the clamping force of thespring 17 between the detent 16 and the base 14.

FIG. 4b shows the coupling element 13 after rotation about the locationof engagement between the base 14 and the base surface 19. There isstill an engagement between the base 14 and the base surface 19, butthere is no longer contact between the detent 16 and the detent surface20. As a result, the coupling element 13 is free to move out of therecess 11.

FIG. 4c shows the coupling element 13 moved out of the recess 11. Thecannula 2 which is connected to the coupling element 13 is no longerconnected to the cannula insertion device 8.

FIGS. 5a and 5b show another embodiment of a safety device according toan embodiment of the invention.

In the embodiment of FIGS. 5a and 5b , the safety device comprises acannula retraction device 30 arranged to automatically retract thecannula 2 in a retraction direction RD, when the force exerted on thedistal end of the cannula 2 in a direction perpendicular to theinsertion direction results in exceeding the safety threshold value.

The retraction direction RD is parallel but opposite to the insertiondirection ID to ensure that the cannula 2 is pulled out of the body partof the human or animal with minimal damage to the tissue of the bodypart in which the cannula 2 is placed.

The cannula retraction device 30 comprises a linear guide 31 extendingin the retraction direction RD and mounted on the cannula insertiondevice 8. A stop element 32 connected to the cannula 2 is arranged inthe linear guide 31 and slidably movable between an insertion position,as shown in FIG. 5a , and a retracted position, as shown in FIG. 5b . Aspring element 33 is arranged to bias the stop element 32 and therewiththe cannula 2 to the retracted position.

Blocking devices 34 are arranged to block movement of the stop element32 from the insertion position to the retracted position. The blockingdevices 34 comprise detent mechanisms that bias a detent on a stopsurface 35 of the stop element 32.

During insertion of a cannula 2 into a body part, the stop element 32 isarranged in the insertion position as shown in FIG. 5a . A transverseforce exerted on the distal end of the cannula 2 will result in a torqueexerted on the stop element 32. When the torque on the stop element 32is below the safety threshold value as provided by the blocking devices34, the blocking devices 34 will keep the stop element 32 in theinsertion position.

However, when the torque on the stop element 32 resulting from thetransverse force exerted on the distal end of the cannula 2 results inexceeding the safety threshold value, the stop element 32 will rotateout of the blocking device 32. As a result, the spring element 35 is nolonger blocked to move the stop element 32 along the linear guide 31 tothe retracted position as shown in FIG. 5 b.

Due to the movement of the stop element 32 from the insertion positionto the retracted position, the cannula 2 will make a movement in theretraction direction RD, i.e. parallel but opposite to the insertiondirection ID. This result in a retraction of the cannula 2 from the bodypart in which it was inserted.

The cannula retraction device 30 will also retract the cannula 2 fromthe body part in which it was inserted, when a force exerted on a distalend of the cannula 2 in a direction parallel to the insertion directionID results in exceeding a second safety threshold value. When a force inthe retraction direction RD exceeds the second safety threshold value,the stop element 32 will be simultaneously pushed out of both detentmechanisms 34. The spring element 35 will consequently push the stopelement 32 along the linear guide to the retracted position shown inFIG. 5b , therewith moving the cannula 2 also to the retracted position.

In an alternative embodiment, the cannula retraction device 30 may bedesigned such that the cannula 2 will only be retracted from the bodypart in which it was inserted, when a force exerted on the distal end ofthe cannula 2 in a direction parallel to the insertion direction IDresults in exceeding a respective safety threshold value.

FIG. 6 shows a further embodiment of a cannula insertion system 1comprising an active cannula holder 40 controlled by the control device5. In an alternative embodiment, the active cannula holder may also becontrolled by its own control device, or any other suitable controldevice.

The active cannula holder 40 comprises a holding device 41 having anactuator controlled by the control device 5 to switch the holding device41 between a holding state and a release state. In the holding state theholding device 41 will hold the cannula 2 placed in the holding device41. In the release state, the holding device 41 will release the cannula2, i.e. the cannula will no longer held by the holding device 41.

The holding device 41 may for example comprise an active gripper thatcan be arranged in a gripping position (holding state) and anon-gripping position (release state) or an electromagnet that can bearranged in a magnetized state (holding state) and a non-magnetizedstate (release state)

A sensor 42 is provided to measure a signal representative for the forceexerted on a distal end of the cannula in a direction perpendicular tothe insertion direction ID. The sensor 42 is a sensor arranged tomeasure a torque exerted on the cannula at the location where thecannula 2 is held by the active cannula holder 40 due to a force exertedon a distal end of the cannula 2. During normal use, the holding device41 will be in the holding state. When the torque measured by the sensor42 exceeds the safety threshold value, the control device 5 will controlthe holding device 41 to switch from the holding state to the releasestate to release the cannula 2 from the cannula insertion device 8.

In an alternative embodiment, the sensor may also be a sensor thatdetermines a sensor signal representative for a position or a rotationalposition of the cannula 2, for example a camera sensor. The sensor mayalso be arranged at another location than the location of the activecannula holder 40.

The control device may further be arranged to control the cannula holder40 to release the cannula 2 when another safety criterion is notfulfilled. Such safety criterion may for example be based on an errordetection of operating parameters of the cannula insertion system 1.When an undesired value of an operating parameter is detected an errorsignal may be established in the control device or sent to the controldevice, and the control device may control the cannula holder 40 torelease the cannula 2.

Such error may for instance relate to a temperature level in the cannulainsertion system exceeding a maximum allowable temperature level, asignal indicating that a needle is not properly coupled to the needleinsertion device 8 or that the cannula 2 is not properly aligned withthe insertion direction ID of the cannula insertion device 8. Thecontrol device may also be arranged to control the cannula holder 40 torelease the cannula 2, when there is a failure in the power provision ofthe cannula insertion system.

Further, the control device may also be arranged to control the cannulaholder 40 to release the cannula 2, when a force exerted on a distal endof the cannula 2 in a direction parallel to the insertion direction IDresults in exceeding a second safety threshold value.

In an alternative embodiment of a cannula insertion system according toan aspect of the invention, a sensor 42 is provided to measure a signalrepresentative for the force exerted on a distal end of the cannula 2 ina direction perpendicular and/or parallel to the insertion direction ID.This sensor signal may be provided to the control device 5. In thisembodiment, the control device 5 may be arranged to control thepositioning system 9 and/or the cannula insertion device 8 to retractthe cannula 2 in the retraction direction RD when the force exerted onthe distal end of the cannula 2 in a direction perpendicular to theinsertion direction ID results in exceeding of the safety thresholdvalue.

In an embodiment, in which a biasing element is provided toautomatically move the cannula to the retracted position when the linearinsertion actuator 8 a is shut off, the control device 5 may also beconfigured to shut off the linear insertion actuator 8 a when the forceexerted on the distal end of the cannula 2 in a direction perpendicularand/or the insertion direction ID results in exceeding of the respectivesafety threshold value.

In the embodiment, shown in FIG. 6, the cannula holder sensor 25 isarranged on the ultrasound transducer positioning device 4. From thislocation, the cannula holder sensor 25 can directly measure the positionof the cannula 2 with respect to the ultrasound transducer 3. Thisposition can be used to properly align the cannula 2 with the insertionlocation of the cannula 2 as determined with a sensor signal obtainedwith the ultrasound transducer 3.

FIG. 7 shows an embodiment of a cannula retraction device 30 to be usedin a cannula insertion system. The cannula retraction device 30 isarranged to automatically retract the cannula 2 in a retractiondirection RD, in case there is a power outage. The retraction directionRD is parallel but opposite to the insertion direction ID to ensure thatthe cannula 2 is pulled out of the body part of the human or animal withminimal damage to the tissue of the body part in which the cannula 2 isplaced.

The cannula retraction device 30 comprises a linear guide 31 extendingin the retraction direction RD and mounted on the cannula insertiondevice 8. A stop element 32 connected to the cannula 2 is arranged inthe linear guide 31 and slidably movable between an insertion position,as shown in solid lines in FIG. 7, and a retracted position, as shown indashed lines in FIG. 7. A spring element 33 is arranged to bias the stopelement 32 and therewith the cannula 2 to the retracted position.

Blocking devices 50 are arranged to block movement of the stop element32 from the insertion position to the retracted position. The blockingdevices 34 each comprise a detent 51 that is biased, in the insertionposition, on a stop surface 35 of the stop element 32.

The blocking devices 50 are electrically operated. Only when theblocking devices 50 are energized the detents 51 will be pushed towardseach other to block the stop element 32 therebetween. As soon as theblocking devices 50 are no longer provided with energy, the detents 51will no longer be pushed towards each other to block the stop element32, and the stop element 32 will be moved by the spring element 33 tothe retracted position.

Thus, during normal use of the cannula insertion system, the blockingdevices 50 will hold the cannula 2 in the insertion position, thatallows the cannula 2 to be inserted into a human or animal body. In casea power outage occurs, the blocking devices 50 will no longer beenergized, as a result thereof, the detents 51 will no longer be pushedagainst the stop surfaces 35, and the cannula will move to the retractedposition. In this retracted position, the cannula 2 cannot be arrangedin the animal or human body. In an embodiment, the detents 51 may bebiased away from the respective stop surfaces 35, for example by aspring, to actively move the detents 51 away from the stop surfaces 35to facilitate movement of the stop element 32 from the insertionposition to the retracted position.

Aspects of the invention may be described by one or more of thefollowing embodiments:

1. A cannula insertion system for inserting a cannula into a human oranimal body, comprising:

-   -   a cannula; and    -   a cannula insertion device to hold and insert the cannula into        the human or animal body in an insertion direction;    -   haracterized in that the cannula insertion system comprises a        safety device configured to retract the cannula or to release        the cannula from the cannula insertion device, in case a safety        requirement is not met.

2. The cannula insertion system of embodiment 1, wherein safety deviceconfigured to retract the cannula or to release the cannula from thecannula insertion device when a force exerted on a distal end of thecannula in a direction perpendicular and/or parallel to the insertiondirection results in exceeding a respective safety threshold value.

3. The cannula insertion system of embodiment 1 or 2, wherein the safetydevice comprises a cannula holder arranged to:

-   -   hold the cannula if the force exerted on the distal end of the        cannula in the direction perpendicular and/or parallel to the        insertion direction is below the respective safety threshold        value, and    -   release the cannula if the force exerted on the distal end of        the cannula in the direction perpendicular and/or parallel to        the insertion direction results in exceeding the respective        safety threshold value.

4. The cannula insertion system of any of the embodiments 1-3, whereinthe cannula holder comprises:

-   -   a coupling element arranged on one of the cannula and cannula        insertion device;    -   a base and a detent mechanism on the other of the cannula and        cannula insertion device;    -   wherein the coupling element comprises a base surface to        cooperate with the base and a detent surface, opposite to the        base surface, to cooperate with the detent mechanism,    -   wherein the coupling element is configured to be releasably held        between the base and the detent mechanism, whereby the detent        surface engages the detent mechanism and the base surface        engages the base,    -   wherein movement of the detent surface in a direction        perpendicular and/or parallel to a line on which the detent        mechanism and the base are provided will result in release of        the coupling element from the base and the detent mechanism.

5. The cannula insertion system of embodiment 4, wherein the couplingelement is mounted on the cannula and wherein the cannula holdercomprises a housing comprising a recess mounted on the cannula insertiondevice, wherein the recess is arranged to receive the coupling element,wherein the housing supports the detent mechanism at one side of therecess and the base at an opposite side of the recess.

6. The cannula insertion system of embodiment 4 or 5, wherein the detentmechanism and the base are arranged on a line parallel to the insertiondirection of the cannula insertion device.

7. The cannula insertion system of any of the embodiments 4-6, whereinthe cannula is a disposable unit, and wherein the coupling element is anintegral part of the cannula.

8. The cannula insertion system of any of the embodiments 1-7, whereinthe cannula insertion system comprises a cannula holder sensor arrangedto determine a position of a cannula held by the cannula holder.

9. The cannula insertion system of any of embodiment 8, wherein thecannula holder sensor is arranged to determine alignment of the cannulawith the insertion direction of the cannula insertion device.

10. The cannula insertion system of any of the embodiments 2-9, whereinthe safety device comprises a sensor arranged to measure a signalrepresentative for the force exerted on the cannula in a directionperpendicular and/or parallel to the insertion direction, wherein thecannula holder is controlled by a control device, and wherein thecontrol device is arranged to control the cannula holder to release thecannula when the force exerted on the distal end of the cannula in adirection perpendicular and/or parallel to the insertion directionresults in exceeding the respective safety threshold value.

11. The cannula insertion system of any of the embodiments 2-10, whereinthe safety device comprises a cannula retraction device arranged toretract the cannula in a retraction direction opposite to the insertiondirection, when the force exerted on the distal end of the cannula inthe direction perpendicular and/or parallel to the insertion directionresults in exceeding the respective safety threshold value.

12. The cannula insertion system of embodiment 11, wherein the cannularetraction device comprises:

-   -   a linear guide extending in the retraction direction and mounted        on the cannula insertion device, in which the cannula is        slidably movable between an insertion position and a retracted        position,    -   a biasing element arranged to bias the cannula to the retracted        position,    -   a blocking element arranged to block movement of the cannula        from the insertion position to the retracted position, when a        force exerted on the distal end of the cannula in the direction        perpendicular and/or parallel to the insertion direction is        below the respective safety threshold value and to allow        movement of the cannula from the insertion position to the        retracted position when the force exerted on the distal end of        the cannula in the direction perpendicular and/or parallel to        the insertion direction results in exceeding the respective        safety threshold value.

13. The cannula insertion system of any of the preceding embodiments,wherein the cannula insertion system further comprises:

-   -   a positioning system supporting the cannula insertion device,        and    -   a control device arranged to control the positioning system to        position, on the basis of a determined location for insertion of        the cannula into the human or animal body, the cannula insertion        device in a suitable position to insert the cannula into the        human or animal body.

14. The cannula insertion system of embodiment 13, wherein the safetydevice comprises a sensor arranged to measure a signal representativefor the force exerted on the cannula in a direction perpendicular to theinsertion direction, and wherein the control device is arranged tocontrol the positioning system and/or the cannula insertion device toretract the cannula in the retraction direction when the force exertedon the distal end of the cannula in a direction perpendicular and/orparallel to the insertion direction results in exceeding the respectivesafety threshold value.

15. The cannula insertion system of any of the embodiments 2-14, whereinthe safety device comprises an adjustment mechanism to adjust therespective safety threshold value.

16. The cannula insertion system of any of the preceding embodiments,wherein the safety device is configured to retract the cannula or torelease the cannula from the cannula insertion device when a poweroutage occurs.

17. The cannula insertion system of any of the preceding embodiments,wherein the cannula insertion system is an autonomous cannula insertionsystem constructed to autonomously insert the cannula into a bloodvessel.

18. The cannula insertion system of any of the preceding embodiments,wherein the cannula is a needle.

19. The cannula insertion system of any of the preceding embodiments,wherein the cannula insertion system is constructed to autonomously drawblood from a blood vessel.

What is claimed is:
 1. A cannula insertion system for inserting acannula into a human or animal body, comprising: a cannula; and acannula insertion device to hold and insert the cannula into the humanor animal body in an insertion direction, wherein the cannula insertiondevice comprises a cannula holder to hold the cannula, wherein thecannula insertion system comprises a cannula holder sensor arranged todetermine whether a cannula is held by the cannula holder and/or todetermine a position of the cannula, for example with respect to theinsertion direction of the cannula insertion device.
 2. The cannulainsertion system of claim 1, wherein the cannula holder sensor isconfigured to determine a position of the cannula in at least one degreeof freedom, for example three or six degrees of freedom.
 3. The cannulainsertion system of claim 1, wherein the cannula holder sensor isarranged to determine alignment of the cannula with the insertiondirection of the cannula insertion device.
 4. The cannula insertionsystem of claim 1, wherein the cannula insertion system comprises acontrol device, wherein the cannula holder sensor is connected to thecontrol device and wherein the control device is configured to checkthat the cannula is properly held by the cannula insertion device beforea procedure of automatic insertion of the cannula into a body part isstarted.
 5. The cannula insertion system of claim 1, wherein theposition of the cannula may be determined with respect to the cannulainsertion device and/or with respect to the human or animal body and/orwith respect to one or more sensors configured to determine one or morefeatures or characteristics of the human or animal body, for examplewith respect to a contact sensor of the cannula insertion system.
 6. Thecannula insertion system of claim 1, wherein the cannula holder isconfigured to releasably hold the cannula.
 7. The cannula insertionsystem of claim 1, wherein the cannula holder sensor is arranged on acannula insertion device positioning system, a sensor or a positioningsystem for such sensor.
 8. The cannula insertion system of claim 1,wherein the cannula insertion system comprises a contact sensor, whereinthe cannula holder sensor is arranged at a location where it candetermine a relative position of the cannula with respect to the contactsensor by measuring from this location both the position of the cannulaand the position of the contact sensor.
 9. The cannula insertion systemof claim 1, wherein the cannula insertion system comprises a contactsensor, wherein the cannula holder sensor is arranged on the contactsensor or a positioning system for such contact sensor to determine arelative position of the cannula with respect to the contact sensor. 10.The cannula insertion system of claim 1, wherein the cannula holdersensor is configured to determine relative position changes between adistal end of the cannula and a target area of the human or animal bodyfor introduction of the cannula.
 11. The cannula insertion system ofclaim 1, wherein the cannula insertion system comprises a safety deviceconfigured to retract the cannula or to release the cannula from thecannula insertion device, in case a safety requirement is not met,wherein the cannula insertion system is arranged to activate the safetydevice to release the cannula from the cannula holder and/or to retractthe cannula if an unexpected movement between the distal end of thecannula and the target area occurs.
 12. The cannula insertion system ofclaim 1, wherein the cannula holder is arranged to adapt a position ofthe cannula to align the cannula with the insertion direction in casemeasurements of the cannula holder sensor indicate that the cannula isnot properly aligned with the insertion direction.
 13. The cannulainsertion system of claim 1, wherein the cannula insertion systemfurther comprises: a positioning system supporting the cannula insertiondevice, and a control device arranged to control the positioning systemto position, on the basis of a determined location for insertion of thecannula into the human or animal body, the cannula insertion device in asuitable position to insert the cannula into the human or animal body.14. The cannula insertion system of claim 1, wherein the cannula is aneedle.
 15. The cannula insertion system of claim 1, wherein the cannulainsertion system is an autonomous cannula insertion system constructedto autonomously insert the cannula into a blood vessel and/or whereinthe cannula insertion system is constructed to autonomously draw bloodfrom a blood vessel.